ID

34507

Description

Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019; ODM derived from: https://clinicaltrials.gov/show/NCT01797965

Link

https://clinicaltrials.gov/show/NCT01797965

Keywords

Versions (1)
  1. 1/18/19 1/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT01797965

English

Eligibility Relapsing-Remitting Multiple Sclerosis NCT01797965

1 forms  
Criteria
Description

Criteria

must be a subject currently participating in study 205ms301 (nct01064401), or subject currently participating in study 205ms203 (nct01051349) or study 205ms302 (nct01462318) who has completed end of study visit (week 96 or later).
Description

Study Subject Participation Status | Multiple Sclerosis Clinical Trial Specified | Clinic Visits Completed

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
UMLS CUI [3,1]
C0008952
UMLS CUI [3,2]
C0205197
women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
any subject who permanently discontinued study treatment in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318) prior to the end of the study treatment period, or had an early termination visit in study 205ms301, study 205ms203 (nct01051349) or study 205ms302 (nct01462318).
Description

Study Subject Participation Status | Multiple Sclerosis Clinical Trial Specified | Therapeutic procedure Discontinued | Termination Clinic Visit

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C1692758
UMLS CUI [4,2]
C0008952
any significant change in the subject's medical history that would preclude administration of biib019, including laboratory tests or a current clinically significant condition that, in the opinion of the investigator, would have excluded the subject's participation in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318).
Description

Medical History Change Preventing Daclizumab HYP | Laboratory Procedures Study Subject Participation Status Excluded | Medical condition Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C4042011
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
the investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this study 205ms303.
Description

Factor Preventing Clinical Trial Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0087111
note: other protocol-defined inclusion/exclusion criteria may apply.
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT01797965

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Subject Participation Status | Multiple Sclerosis Clinical Trial Specified | Clinic Visits Completed
Item
must be a subject currently participating in study 205ms301 (nct01064401), or subject currently participating in study 205ms203 (nct01051349) or study 205ms302 (nct01462318) who has completed end of study visit (week 96 or later).
boolean
C2348568 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0008952 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Study Subject Participation Status | Multiple Sclerosis Clinical Trial Specified | Therapeutic procedure Discontinued | Termination Clinic Visit
Item
any subject who permanently discontinued study treatment in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318) prior to the end of the study treatment period, or had an early termination visit in study 205ms301, study 205ms203 (nct01051349) or study 205ms302 (nct01462318).
boolean
C2348568 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1692758 (UMLS CUI [4,1])
C0008952 (UMLS CUI [4,2])
Medical History Change Preventing Daclizumab HYP | Laboratory Procedures Study Subject Participation Status Excluded | Medical condition Study Subject Participation Status Excluded
Item
any significant change in the subject's medical history that would preclude administration of biib019, including laboratory tests or a current clinically significant condition that, in the opinion of the investigator, would have excluded the subject's participation in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318).
boolean
C0262926 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C4042011 (UMLS CUI [1,4])
C0022885 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Factor Preventing Clinical Trial Treatment
Item
the investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this study 205ms303.
boolean
C1521761 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Eligibility Criteria Study Protocol
Item
note: other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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